PANDORA Study

Study Name

PET Imaging and Lymph Node Assessment of IRIS in Persons with AIDS

Study Number

14-I-0124

Goal of Study

This study will look for the development of IRIS (Immune Reconstitution Inflammatory Syndrome), a condition that can happen in patients who are infected with HIV, after they begin treatment with antiretroviral therapy (ART). Taking these drugs can lead to a rapid improvement in the body’s ability to fight infections, but this sudden improvement can cause some or all of the symptoms of a disease that the patient already has to become worse, or cause new symptoms to appear. As an example patients can develop fever, large lymph nodes, or other complications, or a new disease can be diagnosed that was silent before ART.

In this study, we will closely follow you after starting you on HIV therapy to see if you develop any conditions like these that could be related to IRIS. The purpose of the study is to find out what causes IRIS, what happens after a patient has it, how we manage it and how can we better define what it is.

Study Regimen

During your initial visit, you will have a review of your medical history and a short physical examination and additional blood tests drawn that will include CD4+ T cell count, HIV viral load and safety labs. Food and Drug Administration approved HIV medications will be provided at this visit. For your convenience and if you agree, you may be admitted to the hospital to complete all the procedures and testing. During these visits you will have medical testing done that is necessary for the protocol and your clinical HIV care. Medications to treat possible infections or used to prevent infections may be given to you in this visit.

The total duration of the study for each participant is approximately one year. After you start your HIV medications, you will be seen in clinic after 2, 4, 8, and 12 weeks approximately from the day you started ART and then about every 12 weeks (3 months). The study team may offer some participants an additional year on study. If you participate in the extra year on study you will need to get your HIV medications through your doctor in the community. We will only provide medications for HIV and other infections up until approximately one year or for a short additional period (up to three months) until you can get your HIV medications through your doctor in the community.

About 100 people will take part in this study.

Eligibility Criteria

You are 18 or older and are HIV-positive.

Your absolute CD4 t-cell count has been less than 100 within the past eight weeks.

You have a primary care physician.

You live within 100 miles of the National Institutes of Health (NIH), located in Bethesda, Maryland.

You can commit to staying in the Washington, DC, area for the full 48 weeks of the study.

You have never taken HIV medications, or you used HIV medications for less than three months in total, at least six months ago.

You will allow the NIH to store your lab samples for possible future research.